Monobind AccuBind IgE ELISA Kit - 960 Wells 2525-300E

GUDID 00816870020273

MONOBIND, INC.

Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816870020273
NIH Device Record Key85e69a39-6dd0-4c2a-b676-e0b73d7a46c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonobind AccuBind IgE ELISA Kit - 960 Wells
Version Model Number2525-300
Catalog Number2525-300E
Company DUNS083155515
Company NameMONOBIND, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com
Phone+1(949)951-2665
Emailinfo@monobind.com

Device Dimensions

Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch
Width12 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Handling Environment Temperature
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816870020273 [Primary]

FDA Product Code

DGCIGE, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-11

Devices Manufactured by MONOBIND, INC.

00816870020006 - NeoLumax CLIA Analyzer2024-09-23
00816870020013 - LuMatic CLIA Analyzer2024-09-23
00816870020044 - Immunoassay Plate Washer2024-09-23
00816870020051 - NeoEldex ELISA Analyzer2024-09-23
00816870020068 - PrisMatic ELISA Analyzer2024-09-23
00816870020075 - Autoplex G1 ELISA Analyzer2024-09-23
00816870020082 - Autoplex G2 ELISA + CLIA Analyzer2024-09-23
00816870020402 - PTH Intact AccuBind ELISA Test System - 96 Wells2024-09-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.